BEUDAMED
    FDA Adverse Event Summary report: N

    NON-INVASIVE BLOOD PRESSURE MODULE

    MDR report key: 3072399 · Received April 16, 2013

    Report

    Report Number
    3072399
    Date Received
    April 16, 2013
    Date of Event
    April 7, 2013
    Report Date
    April 16, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEM
    Product Code
    DXN
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CRITICALLY ILL INFANT WAS BEING MONITORED WITH A NON-INVASIVE BLOOD PRESSURE PHILIPS MODULE. THE BLOOD PRESSURE MEASUREMENT WAS HYPOTENSIVE. A PERIPHERAL ARTERIAL LINE WAS PLACED AND MONITORED WITH A PHILIPS INVASIVE BLOOD PRESSURE MODULE. THE MEASUREMENTS WERE GROSSLY HYPERTENSIVE. THE INFANT WAS TREATED FOR HYPERTENSION AND RECOVERED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NON INVASIVE BLOOD PRESSURE MODULE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164151 NON-INVASIVE BLOOD PRESSURE MODULE SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN PHILIPS MEDICAL SYSTEM MP70 *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO